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Efficacy of Ipack Block and Surgeon's Joint Infiltration in Total Knee Arthroplasty

Primary Purpose

Osteo Arthritis Knee

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ipack
Bupivacaine
Peri Articular Infiltration
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring Total knee arthroplasty, Peri articular infiltration, Pack block, Adductor canal catheter

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • ASA (American Society of Anesthesiology) class I-IV
  • age 18-75.

Exclusion Criteria:

  • ASA class V
  • morbid obesity
  • patient refusal
  • patients with chronic pain or on pain medication
  • allergy to LA
  • patients receiving any additional regional techniques
  • coagulopathy
  • patients receiving systemic anticoagulation
  • local infection and procedures anticipated to last more than 5 hours.

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ipack group

Pai (peri articular) group

Arm Description

20 cc of bupivacaine(o.25%) will be injected with the help of ultrasound guidance. Patients will receive adductor canal catheter and peri articular infiltration as well.

Patients will receive adductor canal catheter and peri articular infiltration.

Outcomes

Primary Outcome Measures

Narcotic Consumption
Narcotic consumption in the first 24 hours

Secondary Outcome Measures

Visual Analogue Score (VAS) for Pain
Visual Analogue Score (VAS) for pain - scored from 0 (no pain) to 10 (extreme pain), that is, higher score indicates more pain.
Time to First Dose of Narcotic Administration
PACU Length of Stay
Post-Anesthesia Care Unit (PACU) length of stay (LOS)
Number of Participants With Pain by Location
Location of knee pain as anterior/posterior, medial/lateral
Ambulation Distance
Ambulation distance with assistance on Post-operative Day (POD) 1 as assessed by PT
Bartels Index
Bartels Index to measure activities of daily living (ADL's) on POD 1 as assessed by OT. Total possible scores range from 0-100, with higher scores indicating more independence.

Full Information

First Posted
August 28, 2018
Last Updated
October 11, 2020
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT03653416
Brief Title
Efficacy of Ipack Block and Surgeon's Joint Infiltration in Total Knee Arthroplasty
Official Title
Comparison Between Ipack Block and Periarticular Infiltration in Total Knee Arthroplasty - a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Total knee arthroplasty(TKA) is an effective modality for the treatment of advanced osteoarthritis of the knee joint with excellent outcomes. With 719,000 cases being performed as of 2010, the incidence is expected to increase up to 3.48 million procedures annually by 2030.
Detailed Description
There have been several studies regarding efficacy of peri articular infiltration. IPACK block is a novel technique gaining popularity where one injects local anesthesia safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee. There have been no studies till date comparing the efficacy between IPACK block and Periarticular Infiltration (PAI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
Keywords
Total knee arthroplasty, Peri articular infiltration, Pack block, Adductor canal catheter

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ipack group
Arm Type
Experimental
Arm Description
20 cc of bupivacaine(o.25%) will be injected with the help of ultrasound guidance. Patients will receive adductor canal catheter and peri articular infiltration as well.
Arm Title
Pai (peri articular) group
Arm Type
Active Comparator
Arm Description
Patients will receive adductor canal catheter and peri articular infiltration.
Intervention Type
Device
Intervention Name(s)
Ipack
Intervention Description
IPACK block - local anesthesia injected safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
20 cc of bupivacaine(o.25%) injection
Intervention Type
Procedure
Intervention Name(s)
Peri Articular Infiltration
Other Intervention Name(s)
PAI
Intervention Description
Adductor Canal Catheter and Peri Articular Infiltration
Primary Outcome Measure Information:
Title
Narcotic Consumption
Description
Narcotic consumption in the first 24 hours
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Visual Analogue Score (VAS) for Pain
Description
Visual Analogue Score (VAS) for pain - scored from 0 (no pain) to 10 (extreme pain), that is, higher score indicates more pain.
Time Frame
at 6, 12, 18, and 24 hours post procedure
Title
Time to First Dose of Narcotic Administration
Time Frame
up to 24 hours
Title
PACU Length of Stay
Description
Post-Anesthesia Care Unit (PACU) length of stay (LOS)
Time Frame
average 24 hours
Title
Number of Participants With Pain by Location
Description
Location of knee pain as anterior/posterior, medial/lateral
Time Frame
24 hours
Title
Ambulation Distance
Description
Ambulation distance with assistance on Post-operative Day (POD) 1 as assessed by PT
Time Frame
Post-op Day 1
Title
Bartels Index
Description
Bartels Index to measure activities of daily living (ADL's) on POD 1 as assessed by OT. Total possible scores range from 0-100, with higher scores indicating more independence.
Time Frame
Post-op Day 1

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ASA (American Society of Anesthesiology) class I-IV age 18-75. Exclusion Criteria: ASA class V morbid obesity patient refusal patients with chronic pain or on pain medication allergy to LA patients receiving any additional regional techniques coagulopathy patients receiving systemic anticoagulation local infection and procedures anticipated to last more than 5 hours.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan H Lai, MD,MPH
Organizational Affiliation
Ichan School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29721648
Citation
Sankineani SR, Reddy ARC, Eachempati KK, Jangale A, Gurava Reddy AV. Comparison of adductor canal block and IPACK block (interspace between the popliteal artery and the capsule of the posterior knee) with adductor canal block alone after total knee arthroplasty: a prospective control trial on pain and knee function in immediate postoperative period. Eur J Orthop Surg Traumatol. 2018 Oct;28(7):1391-1395. doi: 10.1007/s00590-018-2218-7. Epub 2018 May 2.
Results Reference
background
PubMed Identifier
35944566
Citation
Bh PP, Jinadu S, Okunlola O, Darkzali H, Lin HM, Lai YH. Integrating IPACK (Interspace between the Popliteal Artery and Capsule of the Posterior Knee) Block in an Enhanced Recovery after Surgery Pathway for Total Knee Arthroplasty-A Prospective Triple-Blinded Randomized Controlled Trial. J Knee Surg. 2023 Oct;36(12):1289-1296. doi: 10.1055/s-0042-1755355. Epub 2022 Aug 9.
Results Reference
derived

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Efficacy of Ipack Block and Surgeon's Joint Infiltration in Total Knee Arthroplasty

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